UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004861
Receipt number R000005784
Scientific Title Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment
Date of disclosure of the study information 2011/01/12
Last modified on 2011/01/12 10:14:08

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Basic information

Public title

Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment

Acronym

Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment

Scientific Title

Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment

Scientific Title:Acronym

Randomized comparative study of pirarubicin (THP) intravesical infusion therapy in non-muscle invasive bladder cancer patients undergoing single treatment immediately after TUR-Bt and those receiving additional maintenance treatment

Region

Japan


Condition

Condition

Non-muscle invasive bladder cancer (pTa-1, G1-2)

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The recurrence-preventive effects and safety of intravesical infusion therapy administered immediately after TUR-Bt of THP (within 24 hours) and additional maintenance therapy will be investigated in patients with low- and intermediate-risk non-muscle invasive bladder cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Recurrence-free rate (survival period and rate) (investigation in all patients, by risk (low and intermediate), and time (at 1, 2, and 3 years))

Key secondary outcomes

Safety


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pirarubicin (THP) at 30 mg will be infused into the urinary bladder for about 30 minutes within 24 hours after TUR-Bt in both groups.
Group A: The course will be observed.

Interventions/Control_2

Group B: THP at 30 mg will be infused into the urinary bladder once a week 9 times.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Non-muscle invasive bladder cancer (pTa-1,G1-2).
(2) Patients who can periodically undergo cystoscopic diagnosis of recurrence after surgery.
(3) Curative resection of all visible tumors can be performed.
(4) Agreement form for this study should be obtained from the patient.

Key exclusion criteria

(1) Patients who previously underwent intravesical infusion therapy with BCG.
(2) Patients who underwent maintenance intravesical infusion therapy with anticancer drugs within 1 year.
(3) Patients with history or present disease of upper urinary tract utotherial carcinoma. (4) Patients with duplex of active other malignant disease.
(5) Function of all organs are without severe dysfunction.
(6) Inappropriate patients for this study judged by the physicians.

Target sample size

260


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuya Mikami

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Urology

Zip code


Address

465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL

075-251-5595

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuya Mikami

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Urology

Zip code


Address

465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL

075-251-5595

Homepage URL


Email

info@kpum-urology.jp


Sponsor or person

Institute

Department of Urology, Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

KPUM-Oncology Study Group

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

京都府立医科大学附属病院(京都府)、松下記念病院(大阪府)


Other administrative information

Date of disclosure of the study information

2011 Year 01 Month 12 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2010 Year 09 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 10 Month 01 Day

Last follow-up date

2015 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 01 Month 12 Day

Last modified on

2011 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005784


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name